Aspiration Pouch 1.5 liters - Medela - Delynov
The Poche d'aspiration 1.5 litres - Medela is a medical device manufactured by le fabricant.
- Compliance: Medical device Class I.
- Manufacturer: le fabricant.
- Reserved for healthcare professionals. Read instructions carefully before use.
Fabricant : Medela, Lättichstrasse 4B · 6340 Baar, Switerland - Usage prévu : Matériel destinés aux professionnels de santé - Lire attentivement la notice. Avertissement et précautions : suivre les instruction de nos modes d’emploi inclus dans les colis de chaque produit - Lire attentivement la notice - Réservé aux professionnels de santé.
What is the 1.5 litres suction bag - Medela - Delynov?
The 1.5 litres suction bag - Medela - Delynov is a medical device from the brand Marque, specifically designed for the collection of fluids during surgical procedures. This consumable integrates into medical suction systems to ensure efficient management of biological liquids. This model is a single-use bag, which simplifies hygiene protocols within the dental office or clinic. As equipment from the brand Marque, this product meets the reliability requirements necessary for suction acts, particularly with Vario type vacuum systems. Its 1.5 litres capacity offers a volume adapted to the current needs of practitioners in oral surgery and implantology.
What are the clinical indications for this device?
The clinical indications for the 1.5 litres suction bag - Medela - Delynov concern the collection and containment of aspirated liquids during surgical procedures. This equipment is intended for healthcare professionals performing dental surgery, periodontology, or implantology procedures requiring constant suction. The single-use nature of this bag guarantees optimal safety by avoiding the risks of cross-contamination between patients. This device from the brand Marque is particularly indicated for interventions requiring clean and secure management of liquid waste, thus ensuring a sterile working environment compliant with the requirements of the intended use.
What are the technical characteristics of this suction bag?
The 1.5 litres suction bag - Medela - Delynov is characterized by its precise capacity of 1.5 litres, ideal for medium to long duration interventions. This device belongs to Class I of medical devices according to current regulations. Designed to be used by healthcare professionals, it adapts perfectly to compatible suction systems, such as the Vario vacuum. Its single-use design allows for rapid and secure disposal after each intervention, limiting the handling of contaminated fluids. The bag structure is designed to resist suction pressure without risk of rupture, ensuring continuity of service during critical phases of surgery.
What are the contraindications for the use of this equipment?
There are no specific contraindications mentioned other than use not in accordance with the instructions of the manufacturer Medela. This device must not be used by persons other than qualified healthcare professionals. It is imperative not to reuse the bag, as its single-use character is essential to prevent healthcare-associated infections. Any use outside the framework of surgical suction for which it was designed is prohibited. Practitioners must read the instructions carefully before any implementation. Failure to follow the assembly instructions on the vacuum can lead to a malfunction of the overall suction system.
What are the precautions for use and warnings?
The precautions for use for the 1.5 litres suction bag - Medela - Delynov require strictly following the instructions for use included in the packages of each product. This equipment is reserved exclusively for healthcare professionals. Before each intervention, the integrity of the bag and its proper connection to the suction system should be checked. As it is a single-use product, it must be disposed of according to the protocols for the treatment of clinical waste with infectious risks (DASRI) after use. It is reminded to read the instructions provided by the manufacturer Medela carefully to ensure safe and efficient handling of the device during fluid collection.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is Medela, located at Lättichstrasse 4B, 6340 Baar, Switzerland. This product is classified as a Class I medical device, meeting the safety and performance standards for equipment intended for healthcare professionals. Medela's rigorous monitoring of manufacturing processes ensures consistent quality for these single-use bags. Compliance with MDR regulation is attested by the associated technical documentation, notably reference G2S 011634 0169 Rev. 02. Practitioners can refer to the manufacturer's instructions to confirm the equipment's compliance with current clinical requirements in force in the European Union.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Pre-gelled | With gelling agent, Gelling agent-free |
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